UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047310 |
|---|---|
| Receipt number | R000053958 |
| Scientific Title | Hair growth effect by using a test article selected based on genetic testing: a randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/03/29 09:45:12 |
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Basic information
Public title
Hair growth effect by using a test article selected based on genetic testing
Acronym
DH study
Scientific Title
Hair growth effect by using a test article selected based on genetic testing: a randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Hair growth effect by using a test article selected based on genetic testing
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use test article for 24 weeks to assess the condition of hair and scalp
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hair thickness measurement, evaluation of scalp condition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use test products selected based on genetic testing for 24 weeks
Interventions/Control_2
No using test articles selected based on genetic testing. For 24 weeks , use test articles that differ from the test results
Interventions/Control_3
Use placebo for 24 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who are aware of thinning hair and can see through the scalp
Key exclusion criteria
1. Factors that may affect the results of the test at the evaluation region (disease such as atopic dermatitis and urticaria, inflammation, eczema, trauma, acne, pimples, warts, stains, etc., or traces thereof)
2. Subjects who have received aesthetic medicine (hair transplantation, etc.) or AGA treatment at the evaluation region, or who plan to receive it during the test period
3. Subjects who regularly use medicines, quasi-drugs, cosmetics, health foods, and supplements that claim to have a hair-growth effect.
4. Subjects who have been exposed to UV rays beyond their daily lives, such as long hours of outdoor work, exercise, swimming, leisure, etc. within the past 4 weeks, or who plan to do so during the test period.
5. Subjects who work night shifts and shift work day and night
6. At the time of obtaining consent, it is judged that the subjects is receiving treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) at a medical institution for the treatment or prevention of the disease, or that treatment is necessary.
7. Subjects who have a history of serious or mental illness of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory organs, respiratory organs, endocrine system, immune system, nervous system.
8. Excessive smokers * and alcohol addicts ** and subjects with extremely irregular diets
9. Subjects who are at risk of developing allergies to cosmetics and foods (including subjects who have developed skin abnormalities such as rashes on cosmetics within the past year)
10. Subjects who have participated in other human tests (all tests for humans using cosmetics, foods, pharmaceuticals, quasi-drugs, medical devices, etc.) within the past 4 weeks, or are planning to conduct this test. Subjects who plan to participate in other human studies during the period
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Masatomo |
| Middle name | |
| Last name | Najima |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
info@yakujihou.org
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N.A.
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
DoubleHelix Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Pharmaceutical Law Wisdoms
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574911
master@yakujihou.net
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0060_02_0105.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0060_02_0105.pdf
Number of participants that the trial has enrolled
29
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053958
